Lung Cancer, Untreated Stage IV or Recurrent Squamous Cell Lung Cancers
Conditions
Keywords
Albumin-Bound, Paclitaxel, Gemcitabine, 15-054
Brief summary
The purpose of this study is to test the safety and effectiveness of albumin-bound paclitaxel plus gemcitabine in patients with advanced squamous cell lung cancers. The investigators would like to determine the percentage of patients with squamous cell lung cancers who experience shrinkage of their tumors following treatment with this regimen. This combination of drugs is not a standard therapy for patients with squamous cell lung cancers. However, each of these drugs, when given alone or with other chemotherapies, is FDA-approved for the treatment of this disease.
Interventions
DRUGgemcitabine
DRUGalbumin-bound paclitaxel
Sponsors
Celgene Corporation
Miami Cancer Institute
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell lung cancer * Newly diagnosed untreated Stage IV and/or recurrent after adjuvant therapy with metastatic disease * Patients previously treated with immune checkpoint inhibitor therapy are eligible * Measurable disease as per RECIST 1.1 * Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy. * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception method during treatment and for three months after completing treatment * Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential * \< Grade 2 pre-existing peripheral neuropathy (per CTCAE) * Marrow and organ function as follows: * ANC ≥ 1500 cells/mm3 * Platelets \> 100,000 cells/mm3 * Hemoglobin\>9g/dL * Creatinine clearance ≥ 40mL/min * Bilirubin ≤ 1.5 mg/dL * AST/ALT≤2.5 x upper limit of normal range (ULN), * alkaline phosphatase ≤ 2.5 X upper limit of normal, unless bone metastasis in present in the absence of liver metastasis
Exclusion criteria
* Prior treatment with albumin-bound paclitaxel or gemcitabine * Prior systemic anticancer therapy for advanced squamous cell lung cancer * Untreated brain metastasis. Patients with treated brain metastases who are off steroids are eligible * Peripheral neuropathy greater than grade 1 * Malignancies within the past 5 years other than non-melanoma skin cancer or insitu cervical cancer status post treatment * Patients with other serious medical illnesses including, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements * Class III or IV congestive heart failure by New York Heart Association
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 1 year | defined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Evaluated for Toxicity | 1 year | AE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Albumin-Bound Paclitaxel and Gemcitabine During each 21-day cycle, albumin-bound paclitaxel at 100mg/mg2 over 120 minutes and gemcitabine at 1000mg/m2 over 30 minutes will be given intravenously on days 1 and 8 of each 21 day cycle. Treatment will continue until disease progression or intolerable side effects. After the 4th cycle of treatment, patients will have the option of discontinuing gemcitabine and proceeding with weekly albumin-bound paclitaxel as maintenance therapy. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Albumin-Bound Paclitaxel and Gemcitabine |
|---|---|
| Age, Continuous | 70 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 21 / 40 |
| other Total, other adverse events | 37 / 40 |
| serious Total, serious adverse events | 7 / 40 |
Outcome results
Primary
Overall Response Rate
defined as the percentage of patients with complete or partial responses based on RECIST 1.1, at any time prior to disease progression, out of all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Albumin-Bound Paclitaxel and Gemcitabine | Overall Response Rate | Partial Response | 18 Participants |
| Albumin-Bound Paclitaxel and Gemcitabine | Overall Response Rate | Complete Response | 1 Participants |
| Albumin-Bound Paclitaxel and Gemcitabine | Overall Response Rate | Not Evaluated, withdrew from study | 5 Participants |
| Albumin-Bound Paclitaxel and Gemcitabine | Overall Response Rate | Stable Disease | 12 Participants |
| Albumin-Bound Paclitaxel and Gemcitabine | Overall Response Rate | No Response | 4 Participants |
Secondary
Participants Evaluated for Toxicity
AE's will be collected, tabulated according to CTCAE version 4.0 and summarized using descriptive statistics.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Albumin-Bound Paclitaxel and Gemcitabine | Participants Evaluated for Toxicity | Evaluable for toxicity | 37 Participants |
| Albumin-Bound Paclitaxel and Gemcitabine | Participants Evaluated for Toxicity | Not evaluable for toxicity | 3 Participants |